Fastum, gel 2.5% 50 g

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drugs (NSAIDs) for topical use

ATC code: M02AA10

Pharmacological properties

Pharmacodynamics

The mechanism of action of the drug is associated with inhibition of prostaglandin synthesis. Ketoprofen has analgesic and anti-inflammatory effects. Ketoprofen penetrates through the skin and reaches the site of inflammation, allowing local treatment of painful lesions (joints, tendons, ligaments and muscles).

Pharmacokinetics

When applied topically ketoprofen penetrates into the center of inflammation through the skin, absorption of ketoprofen from the center of inflammation is extremely slow (gel bioavailability – about 5%). After application of ketoprofen in dose of 50-150 mg the concentration in plasma is 0.08-0.15 mkg/ml in 5-8 hours. It practically does not cumulate in the body. The elimination half-life is 1-3 hours.

The binding to plasma proteins is 60-90%. It is eliminated mainly through the kidneys as glucuronide; approximately 90% of the administered dose is eliminated within 24 hours.

Indications

Radiculitis, Contusions, Pain after injuries and operations, Back pain, Osteoarthritis, Lumbago, Osteochondrosis, Sprains and strains, Pain, Sciatica, Swelling after injuries and operations, Myalgia (muscle pain), Neuralgia, Myositis, Rheumatoid arthritis, Pain in joints (arthralgia), Arthrosis and arthritis, Pain in the neck.p> – pain of traumatic origin (injuries, bruises, sprains and muscles)
– tension and stiffness of the neck muscles;
– lumbago (pain in the lumbosacral spine);
– muscular and bone-joint pain of rheumatic origin.

Active ingredient

Ketoprofen

Composition

100 g of the gel contains:

The active ingredient: ketoprofen – 2.50 g.

Excipients: carbomer, ethanol 96%, neroli flavoring, lavandin flavoring, trolamine (triethanolamine), purified water.

How to take, the dosage

For external use.

5-10 cm strip of the gel is applied as a thin layer on the affected area or skin over the lesion 1 to 3 times a day and lightly rubbed.

The drug Fastum® can also be used in combination with physiotherapy (phonophoresis and ionophoresis).

Interaction

External use of ketoprofen in the form of a gel may increase the effect of drugs causing photosensitization. Other interactions have not been established. However, regular monitoring of the international normalized ratio (INR) is recommended in patients taking coumarin anticoagulants.

Special Instructions

Do not apply the gel on damaged (including open wounds) and inflamed skin!

Avoid getting the gel on mucous membranes and in the eyes (risk of conjunctival irritation).

Wash hands thoroughly after each use of the product. Do not use in the form of hermetic dressings. Do not exceed the recommended duration of treatment, as the increase in time of use increases the risk of contact dermatitis and photosensitization reactions.

In order to avoid any symptoms of hypersensitivity or photosensitization, the patient should avoid direct sunlight (including tanning) during treatment and for two weeks after application, we recommend covering the treatment area with clothing.

Patients with renal, cardiac or hepatic insufficiency should be cautious when using Fastum®; there have been single reports of systemic adverse effects associated with renal damage.

The drug should be discontinued in case of any skin reactions, including reactions when simultaneously applying sunscreens or other cosmetics containing the organic sunscreen octocrylene. External use of the drug in large quantities may cause systemic side effects (hypersensitivity, bronchial asthma, gastrointestinal and renal disorders).

There have been reports of localized skin reactions, which may subsequently extend beyond the area where the drug was applied. Rare events include cases of more severe reactions, such as bullous or eczema fluktenuosa, which may spread and become generalized.

The risk of systemic side effects increases depending on the amount of gel applied, the area of skin treated, the condition of the skin, and the duration of treatment (so do not exceed the maximum recommended duration of treatment).

Avoid exposure to sunlight or UV rays during treatment and for two weeks after treatment.

Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of developing allergic reactions to aspirin and/or NSAIDs than other people.

Influence on the ability to drive vehicles and mechanisms

The drug Fastum® does not affect the ability to drive vehicles and mechanisms.

Synopsis

Colorless, almost transparent gel of viscous consistency, with a characteristic odor.

Contraindications

– hypersensitivity to ketoprofen or other components of the drug, thiaprofenic acid, fenofibrate, acetylsalicylic acid or other NSAIDs (history of asthma symptoms, urticaria or rhinitis, caused by taking the drugs);
– history of skin hypersensitivity to solar radiation (photosensitization);
– history of skin allergy to ketoprofen, thiaprofenic acid, fenofibrate, sunscreens or perfumes;
– sun exposure to the treated sites, including indirect sunlight and solarium during the course of application of the product and 2 weeks after application, pathological skin changes such as acne, eczema, infected abrasions, wounds (in the gel application site);
– children under 12 years of age (effectiveness and safety has not been studied);
– third trimester of pregnancy.

With caution
– liver and kidney function disorders;
– heart failure;
– older age (older patients are more prone to adverse reactions when using nonsteroidal anti-inflammatory drugs).

Side effects

Possible side effects of the preparation Fastum® are given according to the descending frequency of their occurrence: very common (≥ 10%), common (≥ 1%, < 10%), infrequent (≥ 0,1%, < 1%), rare (≥ 0,01%, < 0,1%), very rare (< 0,01%).

Skin disorders
Infrequent: erythema, pruritus, eczema, burning sensation;
Rare: photosensitization, bullous dermatitis, urticaria;
Very rare: contact dermatitis, angioedema.

Gastrointestinal tract disorders
Very rare: peptic ulcer, gastrointestinal bleeding, diarrhea.

The immune system
Very rare: anaphylactic reactions, hypersensitivity reactions.

Urinary system disorders
Very rare: renal failure or exacerbation of existing renal failure.

Overdose

Extremely low systemic absorption of the drug active substance in external use makes overdose unlikely.

If accidental ingestion of large amounts of the drug may manifest systemic side effects.

Treatment should be symptomatic, as in overdose of NSAIDs for oral use.

Pregnancy use

In the first and second trimesters of pregnancy

There were no teratogenic or embryotoxic effects of the drug in studies on mice and rats. In a study in rabbits, a small embryotoxic effect was noted, probably related to maternal toxicity.

Because safety studies of ketoprofen in pregnant women have not been conducted, its use in the first and second trimester of pregnancy should be avoided.

In the third trimester of pregnancy

All inhibitors of prostaglandin synthesis, including ketoprofen, cause toxic damage to the cardiopulmonary system and the fetal kidneys. At the end of pregnancy, both the mother and the baby may have prolonged bleeding times. Because of this, ketoprofen is contraindicated in the third trimester of pregnancy.

Breastfeeding

There are no data on the penetration of ketoprofen into the mother’s milk. Ketoprofen is not recommended for use in breastfeeding mothers.

Similarities

Ketonal, OKI, Bystromgel, Febrofid, Flamax forte, Ketoprofen, Flamax, Fastum, Rocketal Rompharm, Pentalgin extra-gel, Ketonal DUO, Ketoprovel, OKI ACT, Brustel